CLASS II ONGOING Device recall · Reported 8 Dec 2021 · FDA Enforcement Report
Halyard Sterling Zero Nitrile Powder-free Exam Gloves recalled
O&M Halyard is recalling Halyard Sterling Zero Nitrile Powder-free Exam Gloves, Sizes XS, S, M, L, and XL, distributed nationwide in the US. The recall was initiated on 27 Sep 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0317-2022
- FDA event ID
- 88846
- Recalling firm
- O&M Halyard, Alpharetta, GA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 Sep 2021
- FDA classified
- 1 Dec 2021
- Reported
- 8 Dec 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Masks, Gloves & PPE
Timeline
| 27 Sep 2021 | Recall initiated by company | |
| 1 Dec 2021 | Classified by FDA | +65 days |
| 8 Dec 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
All lots of the glove may discolor and lose elasticity upon aging, resulting in the inability of the user to don the gloves without tearing.
Product as listed by the FDA
HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL
Where it was distributed
Worldwide distribution - US Nationwide and the countries of EU/Canada.
Questions about this recall
Why was it recalled?
All lots of the glove may discolor and lose elasticity upon aging, resulting in the inability of the user to don the gloves without tearing.
Which lots are affected?
All lots of the following sizes: a. XS, REF 47459, UDI (01)20680651474593 b. S, REF 47460, UDI (01)20680651474609 c. M, REF 47461, UDI (01)20680651474616 d. L, REF 47462, UDI (01)20680651474623 e. XL, REF 47463, UDI (01)20680651474630
Where was it sold?
Worldwide distribution - US Nationwide and the countries of EU/Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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